Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.
- Conditions
- Lymphoma, B-CellLeukemia, B-cellSolid TumorLymphoma, Non-HodgkinGraft Vs Host Disease
- Interventions
- Registration Number
- NCT03229200
- Lead Sponsor
- Pharmacyclics Switzerland GmbH
- Brief Summary
Multicenter, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region.
- Detailed Description
Multicenter, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region.
Subjects enrolled in this treatment protocol will receive oral continuous dosing with ibrutinib at the same dose and schedule they were receiving at the end of the respective parent study. Treatment may be continued as long as the subjects continue to derive benefit from treatment with ibrutinib until such time that ibrutinib becomes commercially available for the indication of the parent study.
Clinical evaluations (including safety assessments) will be performed per local standard of care for each disease that was studied in the parent protocol. At each visit, all ongoing and new onset non-serious AEs leading to dose reduction or discontinuation, serious adverse events (SAEs), adverse events of special interest (AESI), pregnancy events, other malignancies, and special reporting situations will be recorded.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 600
- Subject must have participated in an eligible ibrutinib clinical trial, may derive clinical benefit from continued treatment or restart of treatment with ibrutinib in the opinion of the treating physician and does not have access to commercial ibrutinib within their region and/or the drug is not reasonably accessible to the patient within the respective region.
- Ongoing continuous treatment with ibrutinib.
- Subject must have completed all assessments in their parent protocol and want to continue treatment with ibrutinib.
- Subject or their legally authorized representative must voluntarily sign and date an informed consent approved by an independent ethics committee (IEC)/institutional review board (IRB) to the long term treatment extension protocol and not withdrawn consent from the parent study.
- Male and female subjects of reproductive potential who agree to use both a highly effective method of birth control and a barrier method during the period of therapy and for 90 days after the last dose of drug.
- Meeting any requirement in the parent protocol to permanently discontinue ibrutinib treatment.
- Any condition or situation which, in the opinion of the treating physician, may interfere significantly with a subject's participation in the protocol.
- Female subjects who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this protocol or within 90 days of last dose of drug treatment. Male subjects who plan to father a child while enrolled in this protocol or within 90 days after the last dose of drug treatment.
- Unwilling or unable to participate in all required evaluations and procedures.
- Unable to understand the purpose and risks of the protocol and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ibrutinib Ibrutinib Treatment with Ibrutinib, once daily until disease progression or unacceptable toxicity.
- Primary Outcome Measures
Name Time Method The objective of protocol PCYC-1145-LT is to provide long-term access to ibrutinib for subjects who meet the selection criteria. The duration will be 3 years and will be re-evaluated. Assessment of percentage of patients rolling over from each parent study.
- Secondary Outcome Measures
Name Time Method Characterize the drug safety profile by collecting long-term safety data for ibrutinib. Up to 3 years and will be re-evaluated. Number of participants with treatment emergent serious adverse events and adverse events of special interest as assessed by CTCAE v4.0.
Trial Locations
- Locations (98)
Concord Repatriation General Hospital - Haematology Clinical Trials
🇦🇺Sydney, New South Wales, Australia
Emory University
🇺🇸Atlanta, Georgia, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
Vanderbilt Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Wenatchee Valley Hospital and Clinics
🇺🇸Wenatchee, Washington, United States
Almazov National Medical Research Centre
🇷🇺Saint Petersburg, Russian Federation
Yaroslavl Regional Clinical Hospital
🇷🇺Yaroslavl, Russian Federation
ICO - Hospital Germans Trias I Pujol
🇪🇸Badalona, Barcelona, Spain
Sunderby hospital
🇸🇪Luleå, Norrbotten, Sweden
Karolinska Universitetssjukhuset, Solna
🇸🇪Solna, Sweden
Azienda Ospedaliera Città della Salute e della Scienza di Torino
🇮🇹Torino, Italy
City Of Hope National Medical Center
🇺🇸Duarte, California, United States
Stanford University
🇺🇸Stanford, California, United States
UCSD Moores Cancer Center
🇺🇸La Jolla, California, United States
Norton Medical Plaza II, 3991 Dutchmans Lane
🇺🇸Louisville, Kentucky, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
San Juan Oncology Associates
🇺🇸Farmington, New Mexico, United States
Northwell Health
🇺🇸New Hyde Park, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Weill Cornell Medical College-New York Presbyterian Hospital
🇺🇸New York, New York, United States
Southeastern Medical Oncology Center
🇺🇸Goldsboro, North Carolina, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
Mid Ohio Oncology/Hematology Inc., DBA The Mark H. Zangmeister Center
🇺🇸Columbus, Ohio, United States
M.D. Anderson Cancer Centre
🇺🇸Houston, Texas, United States
University of Pennsylvania Abramson Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
US Oncology Research, LLC
🇺🇸The Woodlands, Texas, United States
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
Northwest Cancer Specialists, Compass Oncology
🇺🇸Vancouver, Washington, United States
Yakima Valley Memorial Hospital
🇺🇸Yakima, Washington, United States
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Ballarat Health Services
🇦🇺Ballarat, Victoria, Australia
Monash Health-Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
McGill University Health Center
🇨🇦Montréal, Quebec, Canada
University Hospital Hradec Kralove
🇨🇿Hradec Králové, Kralovehradecky Kraj, Czechia
Hematology and Oncology Masaryk University Hospital Brno
🇨🇿Brno, Czechia
University Hospital Pilsen
🇨🇿Pilsen, Czechia
CHU Hotel Dieu
🇫🇷Nantes, Loire Atlantique, France
Charles University Hospital, Prague
🇨🇿Prague, Czechia
Fakultni nemocnice Kralovske Vinohrady
🇨🇿Praha 10, Czechia
Centre Hospitalier Saint Brieuc
🇫🇷Saint-Brieuc, France
Centre Henri Becquerel
🇫🇷Rouen Cedex, France
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
Central Hospital of Southern Pest - National Institute of Hematology and Infectious Diseases, Dept of Hematology and Stem Cell
🇭🇺Budapest, Hungary
Ospedale San Raffaele IRCCS
🇮🇹Milano, Italy
Azienda Sanitaria Universitaria Integrata Udine
🇮🇹Udine, Italy
ASST Grande Ospedale Metropolitano Niguarda
🇮🇹Milano, Italy
Azienda Ospedaliera di Padova
🇮🇹Padova, Italy
Fondazione IRCCS Policlinico San Matteo di Pavia
🇮🇹Pavia, Italy
Kyungpook National University Hospital (KNUH)
🇰🇷Daegu, Korea, Republic of
Middlemore Hospital
🇳🇿Papatoetoe, Auckland, New Zealand
North Shore Hospital
🇳🇿Auckland, New Zealand
Szpital Specjalistyczny w Brzozowie, Oddział Hematologii Onkologicznej z Klinicznym Oddziałem Przeszczepiania Szpiku
🇵🇱Brzozów, Podkarpackie, Poland
SPZOZ ZSM w Chorzowie
🇵🇱Chorzów, Silesia, Poland
SBI of Ryazan region "Regional Clinical Hospital"
🇷🇺Ryazan', Ryazan Region, Russian Federation
Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda, Madrid, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
ICO l'Hospitalet - Hospital Duran i Reynals
🇪🇸Barcelona, Spain
Hospital de Sanata Creus i Sant Pau
🇪🇸Barcelona, Spain
University Hospital of Salamanca
🇪🇸Salamanca, Spain
Södra Älvsborg Hospital Borås
🇸🇪Borås, Sweden
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
China Medical University Hospital
🇨🇳Taichung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Pamukkale University Medical Faculty
🇹🇷Denizli, Pamukkale, Turkey
Ankara Universitesi Tip Fakultesi Hastanesi
🇹🇷Ankara, Turkey
Gazi University
🇹🇷Ankara, Turkey
Dokuz Eylul University
🇹🇷İzmir, Turkey
VKV American Hospital
🇹🇷Istanbul, Turkey
University Hospital of Wales
🇬🇧Cardiff, United Kingdom
Leeds Teaching Hospitals NHS
🇬🇧Leeds, United Kingdom
University College Hospitals NHS Foundation Trust
🇬🇧London, United Kingdom
The Christie NHS Foundation Trust
🇬🇧Manchester, United Kingdom
University of Rochester
🇺🇸Rochester, New York, United States
Providence Health System - Southern California d/b/a Roy and Patricia Disney Family Cancer Center, The Roy & Patricia Disney Family Cancer Center
🇺🇸Burbank, California, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
University of California Los Angeles (UCLA)
🇺🇸Los Angeles, California, United States
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
St. George Hospital
🇦🇺Kogarah, New South Wales, Australia
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Klinika Hematologii i Transplantologii
🇵🇱Gdańsk, Pomorskie, Poland
Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko
🇷🇺Nizhniy Novgorod, Nizhegorodskaya, Russian Federation
Russian Scientific and Research Institute of Hematology and Transfusiology of Federal Medical Biological Agency
🇷🇺Saint Petersburg, Russian Federation
SI Institute of Blood Pathology and Transfusion Medicine of AMSU
🇺🇦Lviv, Ukraine
Eastern Health
🇦🇺Box Hill, Victoria, Australia
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika
🇵🇱Łódź, Poland
CNE CCOHTPC of Cherkasy Regional Council
🇺🇦Cherkasy, Ukraine
CNCE City Clinical Hospital 4 of Dnipro City Council
🇺🇦Dnipro, Ukraine
TRIO - Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
QEII Health Science Centre
🇨🇦Halifax, Nova Scotia, Canada
John Theurer Cancer Center, Hackensack UMC
🇺🇸Hackensack, New Jersey, United States
St Vincent Hospital
🇦🇺Fitzroy, Victoria, Australia
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia